Viewing Study NCT03391271



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Last Modification Date: 2024-10-26 @ 12:37 PM
Study NCT ID: NCT03391271
Status: COMPLETED
Last Update Posted: 2021-09-08
First Post: 2017-12-30

Brief Title: PBMT for the Prevention of CIPN
Sponsor: Hasselt University
Organization: Hasselt University

Study Overview

Official Title: The Use of Photobiomodulation Therapy for the Prevention of Chemotherapy-induced Peripheral Neuropathy a Pilot Trial
Status: COMPLETED
Status Verified Date: 2021-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: ne of the most common cancers in women worldwide is breast cancer A common used therapy in early-stage and metastatic breast cancer involves chemotherapy Taxanes microtubule-targeting agents MTAs are one of the most used chemotherapeutic agents in breast cancer patients Unfortunately this treatment comes with many unfortunate side effects Chemotherapy-induced peripheral neuropathy CIPN is one of these common side effects This condition involves paresthesia numbness andor burning pain in distal limbs Eventually loss of temperature sensation loss of tendon reflexes and pain sensation can occur Yet no therapies have been developed to treat CIPN At the moment only symptom management is possible Not only will this condition affect the patients daily activities but a chemotherapy dose reduction could also be necessary influencing the outcome and overall survival rate of the patient

A new and emerging treatment for CIPN is photobiomodulation therapy PBMT or low-level laser therapy During PBMT visible andor near-infrared laser light is used at the affected area to improve tissue repair and thereby promote functional recovery of peripheral nerves Studies have shown positive results for patients with diabetic neuropathy However no studies have been undertaken specifically for taxane-induced neuropathy TIN

We hypothesize that PBMT is an effective treatment strategy to prevent sensory symptoms associated with TIN This can lead to an improved quality of life for the patient and no need for a chemotherapy dose reduction
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None